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An Exploratory Study of Herombopag for Thrombocytopenia Induced by Chemotherapy Combined With Immunotherapy in NSCLC

Primary Purpose

Non-small Cell Lung Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
herombopag olamine tablets
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The patients signed the informed consent and voluntarily joined the study;
  2. Age 18-75 years old, male or female;
  3. Patients with stage IIIb-IV non-small cell lung cancer diagnosed by histopathology or cytology, who have received and will continue to receive carboplatin-based chemotherapy combined with pemetrexed or nab-paclitaxel, combined with immune checkpoint inhibitors ( ICIs) treatment;
  4. The investigator determined that the patient could receive hetrombopag administration;
  5. Thrombocytopenia of grade 2 or above occurred in the last chemotherapy cycle, defined as platelet count (PLT) ≤ 75×109/L;
  6. The values of laboratory tests performed for screening shall meet the following criteria:

1) Blood routine examination: a) Hemoglobin (HB) ≥ 90 g/L; b) Absolute neutrophil count (ANC) ≥ 1.5×109/L; c) Platelet count (PLT) ≥ 80×109/L; 2) Biochemical tests: a) AST and ALT ≤ 3 times ULN (if there is tumor liver metastasis, ≤ 5 times ULN); b) TBiL ≤ 2 times ULN; c) Cr ≤ 2 times ULN, or creatinine clearance (CrCL) ≥60 mL/min (Cockcroft-Gault formula); 7. Life expectancy at screening ≥12 weeks; 8. ECOG: 0-1; 9. The main organ functions are normal, and there are no serious complications;

Exclusion Criteria:

  1. pregnant or breastfeeding women;
  2. Inability to understand the research nature of the research or to obtain informed consent;
  3. The investigator judges other circumstances that are not suitable for inclusion in the study;
  4. Thrombocytopenia caused by other causes other than those caused by chemotherapy or immunotherapy (such as chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.);
  5. Have unstable angina pectoris, congestive heart failure, uncontrolled hypertension, uncontrolled arrhythmia or recent (within 1 year of screening) history of myocardial infarction;
  6. Those with a history of blood disease or tumor bone marrow infiltration;
  7. Those who received concurrent radiotherapy and those who received pelvic radiotherapy in the past;
  8. Arterial or venous thrombotic events within the past 6 months;
  9. There are currently uncontrollable infections.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    herombopag olamine tablets

    Arm Description

    Outcomes

    Primary Outcome Measures

    Evaluate the response rate of hetrombopag
    response if all of the following criteria are met: 1. No need for platelet transfusion 2. No need to reduce chemotherapy drug dose due to thrombocytopenia 3. No need to delay chemotherapy due to thrombocytopenia) Note: chemotherapy drug dose reduction It was defined as reducing the dose of the original chemotherapy drug by ≥20%, and chemotherapy delay was defined as delaying chemotherapy by >7 days.

    Secondary Outcome Measures

    The lowest platelet value after chemotherapy
    The lowest platelet value after chemotherapy
    Platelet recovery to the highest value after chemotherapy;
    Platelet recovery to the highest value after chemotherapy;
    The duration of platelets ≤50×109/L;
    The duration of platelets ≤50×109/L;
    The time for platelets to recover to more than 100×109/L;
    The time for platelets to recover to more than 100×109/L;
    Incidence of adverse events
    Incidence of adverse events

    Full Information

    First Posted
    February 14, 2022
    Last Updated
    February 14, 2022
    Sponsor
    Henan Cancer Hospital
    Collaborators
    Jiangsu HengRui Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05252091
    Brief Title
    An Exploratory Study of Herombopag for Thrombocytopenia Induced by Chemotherapy Combined With Immunotherapy in NSCLC
    Official Title
    An Exploratory Clinical Study of Herombopag Olamine Tablets for Thrombocytopenia Induced by Chemotherapy Combined With Immunotherapy in Non-small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 20, 2022 (Anticipated)
    Primary Completion Date
    August 20, 2022 (Anticipated)
    Study Completion Date
    September 20, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Henan Cancer Hospital
    Collaborators
    Jiangsu HengRui Medicine Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to explore the safety and efficacy of herombopag olamine tablets for thrombocytopenia induced by chemotherapy combined with immunotherapy in non-small cell lung cancer
    Detailed Description
    To observe and evaluate the safety and efficacy of the TPO receptor agonist herombopag for the secondary prevention of thrombocytopenia caused by chemotherapy combined with immunotherapy in non-small cell lung cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-small Cell Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    herombopag olamine tablets
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    herombopag olamine tablets
    Intervention Description
    The first day of chemotherapy was d1, and the drug was started from d-5, 5 days before chemotherapy, with oral herombopag 5 mg/day for a maximum of 14 days. After chemotherapy, when the thrombocytopenia rises to ≥200×109/L, drug discontinuation can be considered
    Primary Outcome Measure Information:
    Title
    Evaluate the response rate of hetrombopag
    Description
    response if all of the following criteria are met: 1. No need for platelet transfusion 2. No need to reduce chemotherapy drug dose due to thrombocytopenia 3. No need to delay chemotherapy due to thrombocytopenia) Note: chemotherapy drug dose reduction It was defined as reducing the dose of the original chemotherapy drug by ≥20%, and chemotherapy delay was defined as delaying chemotherapy by >7 days.
    Time Frame
    Follow-up to 28 days after the last use of herombopag
    Secondary Outcome Measure Information:
    Title
    The lowest platelet value after chemotherapy
    Description
    The lowest platelet value after chemotherapy
    Time Frame
    Follow-up to 28 days after the last use of herombopag
    Title
    Platelet recovery to the highest value after chemotherapy;
    Description
    Platelet recovery to the highest value after chemotherapy;
    Time Frame
    Follow-up to 28 days after the last use of herombopag
    Title
    The duration of platelets ≤50×109/L;
    Description
    The duration of platelets ≤50×109/L;
    Time Frame
    Follow-up to 28 days after the last use of herombopag
    Title
    The time for platelets to recover to more than 100×109/L;
    Description
    The time for platelets to recover to more than 100×109/L;
    Time Frame
    Follow-up to 28 days after the last use of herombopag
    Title
    Incidence of adverse events
    Description
    Incidence of adverse events
    Time Frame
    Follow-up to 28 days after the last use of herombopag
    Other Pre-specified Outcome Measures:
    Title
    Changes of platelet value in each visit cycle
    Description
    Changes of platelet value in each visit cycle
    Time Frame
    Follow-up to 28 days after the last use of herombopag

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patients signed the informed consent and voluntarily joined the study; Age 18-75 years old, male or female; Patients with stage IIIb-IV non-small cell lung cancer diagnosed by histopathology or cytology, who have received and will continue to receive carboplatin-based chemotherapy combined with pemetrexed or nab-paclitaxel, combined with immune checkpoint inhibitors ( ICIs) treatment; The investigator determined that the patient could receive hetrombopag administration; Thrombocytopenia of grade 2 or above occurred in the last chemotherapy cycle, defined as platelet count (PLT) ≤ 75×109/L; The values of laboratory tests performed for screening shall meet the following criteria: 1) Blood routine examination: a) Hemoglobin (HB) ≥ 90 g/L; b) Absolute neutrophil count (ANC) ≥ 1.5×109/L; c) Platelet count (PLT) ≥ 80×109/L; 2) Biochemical tests: a) AST and ALT ≤ 3 times ULN (if there is tumor liver metastasis, ≤ 5 times ULN); b) TBiL ≤ 2 times ULN; c) Cr ≤ 2 times ULN, or creatinine clearance (CrCL) ≥60 mL/min (Cockcroft-Gault formula); 7. Life expectancy at screening ≥12 weeks; 8. ECOG: 0-1; 9. The main organ functions are normal, and there are no serious complications; Exclusion Criteria: pregnant or breastfeeding women; Inability to understand the research nature of the research or to obtain informed consent; The investigator judges other circumstances that are not suitable for inclusion in the study; Thrombocytopenia caused by other causes other than those caused by chemotherapy or immunotherapy (such as chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.); Have unstable angina pectoris, congestive heart failure, uncontrolled hypertension, uncontrolled arrhythmia or recent (within 1 year of screening) history of myocardial infarction; Those with a history of blood disease or tumor bone marrow infiltration; Those who received concurrent radiotherapy and those who received pelvic radiotherapy in the past; Arterial or venous thrombotic events within the past 6 months; There are currently uncontrollable infections.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    qiming wang
    Phone
    13783590691
    Email
    qimingwang1006@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    zhen he
    Phone
    13523530961
    Email
    13523530961@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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